Tetra PICASSO AD Trial: Study to Evaluate Effects of BPN14770 in Early Alzheimer's Subjects
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|ClinicalTrials.gov Identifier: NCT03817684|
Recruitment Status : Unknown
Verified October 2019 by Tetra Discovery Partners.
Recruitment status was: Active, not recruiting
First Posted : January 25, 2019
Last Update Posted : October 31, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: BPN14770 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||255 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized , Double Blind, Placebo Controlled, 3-Arm Parallel Design Study to Evaluate the Effects of BPN14770 in Patients With Early Stage Alzheimer's Disease|
|Actual Study Start Date :||April 30, 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
Experimental: BPN14770 10mg bid
10 mg bid dose of the Drug BPN14770
Experimental: BPN 14770 25mg bid
25mg bid dose of the Drug BPN14770
|Placebo Comparator: Placebo||
- Repeatable Battery for the Assessment of Neurological Status- Delayed Memory Index (RBANS- DMI) [ Time Frame: Week 13 ]Change from baseline of RBANS-DMI score. Power based on true difference of 7.15 units on normalized mean of score of 100 between 25mg dose Arm vs Placebo
- Repeatable Battery for the Assessment of Neurological Status (RBANS) total score [ Time Frame: Weeks 1,2,4,8,13 ]Comparison of RBANs Total scores to baseline at each timepoint
- Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: Week 8, 13 ]ADCS-ADL total score compared to baseline at each time point
- Mini-Mental State Exam (MMSE) Score [ Time Frame: Weeks 1,2,4,8,13 ]MMSE total score versus baseline at each timepoint
- Clinical Dementia Rating Sum of Boxes Score (CDR-SB) [ Time Frame: Week 13 ]CDR-SB versus Baseline at each timepoint
- Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: Week 1,2,4,8,13 ]CGI-I Score versus Baseline at each timepoint
- Pharmacokinetics: Maximum Drug Plasma Levels [ Time Frame: Weeks 1,4,8,13 ]Maximum Drug plasma concentration levels by study arm
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|Ages Eligible for Study:||55 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Males or females between the ages of 55 and 85 years with a clinical diagnosis of early stage AD, defined according to the following criteria assessed during Screening and at Baseline :
- Clinical Dementia Rating (CDR) score of 0.5 or 1, with Memory Box score of 0.5 or greater
- MMSE score of 20 or greater
- RBANS DMI score ≤ 85 Note: PET imaging for amyloid is not required for diagnosis, which will be made on clinical grounds.
Currently receiving a stable (at least 2 months) dose regimen of donepezil or another cholinesterase inhibitor for treatment of Alzheimer's disease. Doses of these drugs may not be changed during the trial.
Note: Memantine is not permitted during the trial and must be discontinued at least 3 weeks prior to Baseline.
- Modified Hachinski Ischemia score < 4.
- Body mass index (BMI) < 38 kg/m2, inclusive, and body weight of >48 kg (105 pounds) at screening.
- Female subjects must be at least two years post-menopausal (subjected reported menopausal status), surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to first study drug administration), or willing to either (1) utilize hormonal contraception plus one barrier method or (2) use two barrier methods of contraception (e.g. diaphragm and spermicide) from initial screening until one month after taking the final dose. An intrauterine device (IUD) is considered a barrier method of contraception in this study. Male subjects must be willing to inform female partners of their participation in the study and must agree to use adequate contraceptive methods (vasectomy performed at least 6 months prior to first study drug administration, or use at least one barrier method of birth control).
- Able to understand and comply with the study procedures, voluntarily agree to participate in this study, and provide written informed consent prior to start of any study-specific procedures.
- All subjects must have a caregiver who is willing and able to ensure compliance with study medications, visits, and study procedures.
- Any medical or neurological condition (other than early stage AD) that might be a contributing cause to the subject's cognitive impairment.
- History of stroke or multiple (>3 discreet episodes) Transient Ischemic Attacks (TIAs), severe head trauma with cognitive sequelae, uncontrolled seizures, or unexplained prolonged loss of consciousness (> 1 minute) during the past year.
- Clinically significant major psychiatric illness during the past 6 months.
- History of unstable angina, myocardial infarction, chronic heart failure, or clinically significant conduction abnormalities during the past year.
- Clinically significant liver or renal disease.
- Clinically significant abnormality, in the Investigator's judgment, in hematology, chemistry, or urinalysis.
- Positive serology results for hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV).
Abnormal liver function test at the Screening Visit (aspartate aminotransferase or alanine aminotransferase >2
× the upper limit of normal [ULN], or total bilirubin >1.7 × ULN, based on appropriate age and gender normal values). Subjects may be re-screened once.
- Marked hypotension (systolic blood pressure [BP] ˂90 mmHg or diastolic BP ˂50 mmHg) or hypertension (systolic BP ˃160 mmHg or diastolic BP ˃100 mmHg) based on sitting values. O ut-of-range results may be repeated once at Screening, and eligibility must be confirmed at Baseline.
- Marked bradycardia (heart rate ˂45 beats per minute [bpm]) or tachycardia (heart rate ˃115 bpm) based on supine ECG values. Out-of-range results may be repeated once at Screening, and eligibility must be confirmed at Baseline.
- Clinically important conduction abnormalities on ECG, or evidence or history of long QT syndrome based on supine ECG values obtained at Screening. Out-of-range results may be repeated once and eligibility confirmed at Baseline.
- Active gastric or duodenal ulcers or other diseases of the gastrointestinal tract that could interfere with absorption of study drug. Note: Subjects with a history of appendectomy or cholecystectomy may be enrolled.
- Active acute or chronic infectious diseases that would interfere with subject's participation in the study.
- Unable to discontinue centrally active medications (other than cholinesterase inhibitors), including memantine, psychotropic drugs other than SSRIs (which must have been stable for 2 months and remain stable throughout the study), sedative antihistamines or other centrally active medications with potential cognitive effects (e.g., CNS-penetrant beta blockers).
- Unable to discontinue moderate to strong inhibitors or inducers of CYP3A4, CYP2D6, or other cytochromes at least 14 days prior to the first dose of study drug. A complete listing of such inhibitors or inducers may be found in http://medicine.iupui.edu/clinpharm/ddis/main-table (Other prescription or non-prescription drugs such as antihypertensive or cholesterol lowering agents are allowed, if, in the Investigator's judgement, they would not interfere with the study medication or the cognitive testing.)
- A suicidal ideation intensity score of 3 or higher per screening Columbia Suicide Severity Rating Scale (CSSRS) assessment on Day 1 (Baseline) and/or any suicidal behavior within the past 28 days.
- History of chronic alcohol or other substance abuse, including marijuana, within the previous year prior to the Screening visit (per the current edition of the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition: DSM-5), or regular (daily) consumption of alcohol exceeding two bottles of beer, or the equivalent amount of other forms of alcohol (1 serving = 12 oz beer, 5.0 oz wine, or 1.5 oz distilled spirits).
- Inability or unwillingness to comply with the protocol, including performing the cognitive function tests, or likely inability to complete the study.
- Participation in other clinical studies involving investigational drug within the previous 30 days prior to the Screening Visit.
- Donation of blood within 4 weeks, or blood products within 2 weeks, prior to first study drug administration.
- History of clinically significant drug allergy that includes symptoms such as shortness of breath, rash, or edema.
- Clinically significant B12 deficiency within 12 months prior to Visit 1 (Screening). Participants on stable replacement therapy for a minimum of 3 consecutive months immediately prior to Visit 1 (Screening) may be included
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817684
|Study Director:||Scott Reines, MD||Tetra Discovery Partners|
|Responsible Party:||Tetra Discovery Partners|
|Other Study ID Numbers:||
|First Posted:||January 25, 2019 Key Record Dates|
|Last Update Posted:||October 31, 2019|
|Last Verified:||October 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Diseases
Nervous System Diseases
Phosphodiesterase 4 Inhibitors
Molecular Mechanisms of Pharmacological Action